RecruitingPHASE1INTERVENTIONAL

A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive

This study is investigating two types of salbutamol inhalers, which are used to relieve asthma symptoms. Both inhalers deliver salbutamol using different propellants – one uses HFA-152a and the other uses HFA-134a. Researchers want to understand how effective each version is in preventing asthma flare-ups in people with mild asthma, particularly looking at how much is needed to protect against a trigger. The main goal is to compare these two types of inhalers to see if the newer propellant (HFA-152a) works as well as the established one (HFA-134a). This information could help improve asthma treatments in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

Start

14 Aug 2024

Estimated completion

06 Nov 2026

Asthma Mild Asthma

What is this study about?

This study is focusing on salbutamol, a common medication used in 'reliever' inhalers for asthma. We're looking at two different ways this medication can be delivered through a standard puffer inhaler. Both use a propellant – a gas that helps the medicine get from the inhaler into your lungs. One uses a propellant called HFA-134a, which is already widely used. The other uses a newer type, HFA-152a.

The main aim of this research is to see how these two versions of salbutamol compare. Specifically, we want to understand how strong each works and how much is needed to protect against asthma triggers. Researchers will compare how well the newer HFA-152a propelled inhaler works compared to the established HFA-134a propelled inhaler in people who have mild asthma.

By comparing these two types, scientists hope to gather important information that could lead to new or improved asthma treatments. This kind of early-stage study helps us understand the effects of new medications or new ways of delivering existing medications, making sure they are effective and safe for patients.

Key takeaways

This study compares two types of salbutamol inhalers for mild asthma.
One inhaler uses a new propellant (HFA-152a), and the other uses a standard one (HFA-134a).
Its main aim is to see how effective each type is in preventing asthma symptoms.
Participation involves clinic visits and lung function tests.
It's an early-stage study (Phase 1) to gather initial safety and effectiveness information.

Who may be eligible?

To join this study, you need to be a man or a woman between 18 and 65 years old. You should weigh at least 50 kg (about 7 stone 12 pounds) and have a body mass index (BMI) within a healthy range.

You must have a history of asthma for at least 6 months and currently be taking specific asthma medications, such as a short-acting reliever inhaler only, or a low-dose inhaled steroid (with or without a long-acting inhaler). These medications need to have been at a steady dose for at least 12 weeks before the study starts. You also shouldn't have had any severe asthma attacks recently.

For women, you can join if you are not pregnant or breastfeeding, and either can't have children or are using a very reliable method of contraception.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Have you had asthma for at least 6 months?
Are you currently on specific, stable asthma medications (e.g., reliever only, or low-dose inhaled steroid)?
Have you not had any recent severe asthma attacks?
For women, are you not pregnant or breastfeeding, and using reliable contraception if you could have children?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several visits to the study clinic. During these visits, doctors will check your lung function (like how much air you can breathe out) and may ask you to do a 'methacholine challenge test.' This test involves breathing in a small amount of a substance that can make your airways tighten a little, helping doctors measure how sensitive your lungs are and how well the study medication protects you. You'll be given one of the study inhalers (either Salbutamol with HFA-152a, Salbutamol with HFA-134a, or a placebo, which looks like the real thing but contains no active medicine). For some tests, you'll need to stop using your regular reliever inhaler for at least 8 hours, and for other specific medications, for 48 hours. The total duration of your involvement in the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit from being in this study, but your participation will help researchers learn more about asthma treatments, which could benefit others in the future. As with any medication, there's a chance you could experience side effects from the study inhalers, or the methacholine challenge test could briefly tighten your airways. All procedures will be carefully monitored by medical staff. You will be given full details of these potential risks before you decide to join, and remember, you are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is salbutamol?

Salbutamol is a common medicine found in 'reliever' inhalers for asthma. It helps to quickly open up your airways, making it easier to breathe when you have asthma symptoms.

What is a 'propellant' in an inhaler?

A propellant is a gas that helps to push the medicine from the inhaler device into your lungs when you press it. This study is looking at two different types of propellants used with salbutamol.

What is mild asthma?

Mild asthma means your asthma symptoms are generally well controlled, and you may only need to use your reliever inhaler now and then, without frequent severe flare-ups.

Will I know which inhaler I'm using?

This is a 'blinded' study, meaning neither you nor the study doctors will know whether you are receiving the HFA-152a salbutamol, HFA-134a salbutamol, or the placebo. This helps ensure the results are fair.

What is a placebo?

A placebo is an inactive substance or treatment that looks exactly like the real medication but contains no active medicine. It helps researchers compare the true effects of the drug.

How to find out more

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com 877-379-3718 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.